Doppler-guided or Non Doppler-guided Arterial Ligation and Mucopexy for Third Degree Hemorrhoids: That is the Question (HAMLeT)

October 19, 2020 updated by: Societa Italiana di Chirurgia ColoRettale

Multicenter Randomized Controlled Trial of Doppler Guided Hemorrhoid Artery Ligation (DGHAL) and Mucopexy Versus Mucopexy Alone in the Treatment of Grade III Hemorrhoids

Hemorrhoidal disease is one of the most common proctological disease affecting the general population from the mid-teens onward with considerable implications for the National Health Service (NHS) both from an economic point of view and from surgeon's workload.Improved understanding of the pathogenesis of hemorrhoids and of the complications associated with excisional hemorrhoidectomy led to the invention of newer surgical procedures, including Doppler guided hemorrhoidal artery ligation (DGHAL).

This technique was introduced in 1995 by Morinaga et al. and consists in the use of a proctoscope with a Doppler transducer that detect the arterial structures.

Since DGHAL does not involve tissue excision, it is expected to be associated with reduced postoperative pain if compared with hemorrhoidectomy.

In the last decade several devices (THD and AMI/ HAL-RAR - Hemorrhoidal Artery Ligation and Recto Anal Repair) have been developed in order to improve and facilitate the execution of the technique, making easier the procedure.

The hypothesis of the study is that a simple mucopexy procedure by suture-fixation of anal cushion without the aim of a Doppler device, could be as effective as DGHAL and mucopexy to manage prolapsing grade III hemorrhoids.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.

Primary aim of the Hamlet trial is to demonstrate that mucopexy without DGHAL for grade III haemorrhoids have equivalent recurrence rate at 1 year follow up of DGHAL with mucopexy procedure

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic grade III hemorrhoids according to Goligher
  • No other source of anal bleeding than hemorrhoids
  • Written informed consent

Exclusion Criteria:

  • Any previous hemorrhoid surgery
  • Participants expressing clear preference for one of the interventions
  • Pregnancy
  • Inability to understand the informed consent
  • Oral anticoagulants of congenital defects of the coagulation
  • Patients with immunodepression (i.e. HIV)
  • Other proctological diseases (fissures, fistulas, condyloma, etc)
  • IBD involving the anus ore the rectum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mucopexy with Doppler artery ligation
Doppler guided hemorrhoidal artery ligation and mucopexy: Group of patients with III degree hemorrhoids treated by THD or AMI device is introduced into the anal canal. The terminal branches of the rectal artery are detected by the Doppler 2-3 cm above the dentate line. The tip of the instrument is tilted and arteries ligated with a figure-of-eight suture inserted using a special needle-holder. After the haemorrhoid artery ligation, the suture is continued with 3/5 sutures applied 5 mm apart, making sure that the last is at least 5 mm above the dentate line. The suture is then tied to create a hemorrhoidopexy. The procedure is repeated after all artery ligations (6 ligations
Procedure: mucopexy with Doppler artery ligation
Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants
Other Names:
  • DGHAL
Experimental: mucopexy without Doppler artery ligation
Non Doppler guided hemorrhoidal artery ligation and mucopexy: A lubricating gel is applied to the tip of the THD or the AMI device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. the mucopexy will start at two o'clock and repeated at 4, 6 8, 10, 12, in clockwise direction
Procedure: mucopexy without Doppler artery ligation
Hemorrhoids will be treated by mucopexy alone performed in all quadrants
Other Names:
  • NON-DGHAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of recurrences of hemorrhoidal prolapse
Time Frame: 1 year follow up
Recurrence is defined as persistent or recurrent hemorrhoidal prolapse and graded according to Goligher in 4 degrees
1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societa Italiana di Chirurgia ColoRettale

Investigators

  • Principal Investigator: Donato F Altomare, University of Bari, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • siccr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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